Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use

NCT02137512 | Completed Results DMC

• 1 other identifier: Pilot 3 Outpatient CTR
• Study Type: interventional
• Target: 30
• Locations: 4 countries
• Sites: 6

Brief Summary

The purpose of this study is to see if an automated insulin management system ("study system") can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and allows the study participant user to control the whole system, and (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be from Roche. The CGM and pump are similar to the devices that are currently available for people to purchase and use. However, the smartphone device, the CGM sensor type used with it, and the overall study system can only be used for research at this time. The study will be completed by about 24 individuals at 6 centers in the United States and Europe. This study has several phases and will take about 11-14 weeks to complete depending on whether the study participant is a CGM user or not. At selected sites (based on subject eligibility and availability), approximately 10-20 subjects who exhibit safe and competent use of the system at home will be given the option to continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.

Conditions

Type 1 Diabetes

Keywords

Artificial Pancreas

Outcome Measures

Primary Outcomes (1)

• Time Spent <70 mg/dL - Main Phase, Night Only

  Percentage of CGM Measured Glucose Values \<70 mg/dl during study Main Phase, night only (23:00 to 07:00)

  2 weeks

Secondary Outcomes (42)

• Time Spent <70 mg/dL - Main Phase, Day and Night

  2 weeks

• Time Spent <70 mg/dL - Main Phase, Day Only

  2 weeks

• Time in Range 70-180 mg/dL - Main Phase, Day and Night

  2 weeks

• Time in Range 70-180 mg/dL - Main Phase, Night Only

  2 weeks

• Time in Range 70-180 mg/dL - Main Phase, Day Only

  2 weeks

Other Outcomes (12)

• Mean Sensor Glucose - Extension Phase

  3 months

• Change in HbA1c - Extension Phase

  5 months

• Time Spent <3.9 mmol/L (70 mg/dL) - Extension Phase

  3 months

Study Arms (2)

Closed-Loop Control System

EXPERIMENTAL

Use of an investigational control-to-range automated insulin management (artificial pancreas) system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.

Device: Closed-Loop Control System

Sensor-Augmented Pump (SAP)

ACTIVE COMPARATOR

Use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump

Device: Sensor-Augmented Pump (SAP)

Interventions

Closed-Loop Control System DEVICE

This investigational device system included the following components: * DiAs - a smart-phone medical platform; * Dexcom G4 Platinum CGM system connected to DiAs via CGM receiver and USB-Bluetooth relay hardware; * Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; * Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network * Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class

Also known as: Diabetes Assistant (DiAs)

Closed-Loop Control System

Sensor-Augmented Pump (SAP) DEVICE

This commercial device system included the following components: * Dexcom G4 Platinum CGM system; * Roche Accu-Chek insulin pump

Sensor-Augmented Pump (SAP)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year and an insulin pump for at least 6 months.
• Age \>=18 to \<70 years.
• HbA1c \<10.0%; if HbA1c \<6.0% then total daily insulin must be \>=0.5 U/kg
• For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
• Demonstration of proper mental status and cognition for the study.
• Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes
• Hypoglycemia awareness as demonstrated by a Clarke Hypoglycemia Awareness score of 2 or lower
• Access to internet and cell phone service at home, and a computer for downloading device data.
• Living with significant other or family member committed to participating in all training activities, knowledgeable at all times of the participant's location, and being present and available to provide assistance when system is being used at night.
• Commitment to maintaining uninterrupted availability via cell phone and avoiding any overnight travel for the duration of each two-week period using the closed-loop system.
• An understanding of and willingness to follow the protocol and sign the informed consent.

You may not qualify if:

• Admission for diabetic ketoacidosis in the 12 months prior to enrollment.
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment.
• History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist.
• Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
• History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
• Cystic fibrosis.
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
• Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
• Presence of a known adrenal disorder
• Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
• Abnormal renal function test results (calculated GFR \<60); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty
• Active gastroparesis
• If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
• Uncontrolled thyroid disease (TSH undetectable or \>10); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise
• Abuse of alcohol or recreational drugs

Sponsors & Collaborators

• Jaeb Center for Health Research: lead

Study Sites (6)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Montpellier University Hospital

Montpellier, 34295, France

Location

National Center for Childhood Diabetes- Schneider Children's Medical Center

Petah Tikva, 49202, Israel

Location

University of Padova

Padua, 93106, Italy

Location

Related Publications (1)

• Anderson SM, Raghinaru D, Pinsker JE, Boscari F, Renard E, Buckingham BA, Nimri R, Doyle FJ 3rd, Brown SA, Keith-Hynes P, Breton MD, Chernavvsky D, Bevier WC, Bradley PK, Bruttomesso D, Del Favero S, Calore R, Cobelli C, Avogaro A, Farret A, Place J, Ly TT, Shanmugham S, Phillip M, Dassau E, Dasanayake IS, Kollman C, Lum JW, Beck RW, Kovatchev B; Control to Range Study Group. Multinational Home Use of Closed-Loop Control Is Safe and Effective. Diabetes Care. 2016 Jul;39(7):1143-50. doi: 10.2337/dc15-2468. Epub 2016 Apr 13.

  PMID: 27208316 RESULT

Related Links

• Multinational Home Use of Closed-Loop Control Is Safe and Effective

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: John Lum, Artificial Pancreas Project Director
• Organization: Jaeb Center for Health Research

jlum@jaeb.org

8139758690

Study Officials

• Roy Beck, MD, PhD

  Jaeb Center for Health Research

  PRINCIPAL INVESTIGATOR

• Boris Kovatchev, PhD

  University of Virginia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 13, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 29, 2018
• Results First Posted: October 19, 2016

Record last verified: 2018-08

Locations

IL (1); US (3); FR (1); IT (1)